Ortho-Nesic With Capsaicin

Product NDC: 63347-401
11-digit product format: 633470401
Labeler code: 63347
Product ID: 63347-401_9f6beb70-5bdc-42e3-80bd-d2b95af9a9a8
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: GEL
Route: TOPICAL
Labeler: Blaine Labs Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 1995-01-01
Marketing end: 0000-00-00
Substance: CAMPHOR (SYNTHETIC); MENTHOL
Active strength: 0 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63347-401		D	Discontinued by firm	2026-09-09
excluded package	package	63347-401	63347-401-02	D	Discontinued by firm	2026-09-09
excluded package	package	63347-401	63347-401-03	D	Discontinued by firm	2026-09-09
excluded package	package	63347-401	63347-401-04	D	Discontinued by firm	2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63347-401-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63347-401-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63347-401-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63347-401-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63347-401-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63347-401-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63347-401-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63347-401-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63347-401-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63347-401-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63347-401-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63347-401-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63347-401-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63347-401-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63347-401-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63347-401-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63347-401-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63347-401-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63347-401-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63347-401-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63347-401-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63347-401-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63347-401-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63347-401-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63347-401-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63347-401-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63347-401-02	`0efc9e666f02…`	`f202fb6c5f17…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63347-401-01	2022-02-21	9ac9324f-891e-4325-9332-6dfb989a79f5
63347-401-02	2022-02-21	9ac9324f-891e-4325-9332-6dfb989a79f5
63347-401-03	2022-02-21	9ac9324f-891e-4325-9332-6dfb989a79f5
63347-401-04	2022-02-21	9ac9324f-891e-4325-9332-6dfb989a79f5
63347-401-01	2022-01-28	9ac9324f-891e-4325-9332-6dfb989a79f5
63347-401-02	2022-01-28	9ac9324f-891e-4325-9332-6dfb989a79f5
63347-401-03	2022-01-28	9ac9324f-891e-4325-9332-6dfb989a79f5
63347-401-04	2022-01-28	9ac9324f-891e-4325-9332-6dfb989a79f5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63347-401-01	ML - Milliliter	63347-401	2bfdeb48-3f46-48ad-8702-628a2e285b01	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAMPHOR (SYNTHETIC)	ACTIVE INGREDIENT	5TJD82A1ET	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	4
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	4
CAMPHOR (SYNTHETIC)	ACTIVE MOIETY	5TJD82A1ET	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	4
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	4
CAPSAICIN	INACTIVE INGREDIENT	S07O44R1ZM	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	4
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	4
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	4
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	4
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	4
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	4
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	ORTHO-NESIC WITH CAPSAICIN (MENTHOL) GEL [BLAINE LABS INC.]	4

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63347-401-01	63347040101	170 g in 1 TUBE (63347-401-01)	170 g	1995-01-01	0000-00-00	No	No	Current
63347-401-02	63347040102	907 g in 1 BOTTLE, PUMP (63347-401-02)	907 g	1995-01-01	0000-00-00	No	No	Current
63347-401-03	63347040103	3629 g in 1 BOTTLE, PUMP (63347-401-03)	3629 g	1995-01-01	0000-00-00	No	No	Current
63347-401-04	63347040104	85 g in 1 TUBE, WITH APPLICATOR (63347-401-04)	85 g	1995-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ortho-Nesic With Capsaicin - Blaine Labs Inc.	Blaine Labs Inc.	2023-12-21	HUMAN OTC DRUG LABEL	10